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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2019-0767

2. Registrant Information.

Registrant Reference Number: 180178266

Registrant Name (Full Legal Name no abbreviations): Wellmark International

Address: 100 Stone Road West, Suite 111

City: Guelph

Prov / State: Ontario

Country: Canada

Postal Code: N1G5L3

3. Select the appropriate subform(s) for the incident.

Domestic Animal

4. Date registrant was first informed of the incident.

24-OCT-18

5. Location of incident.

Country: UNITED STATES

Prov / State: PENNSYLVANIA

6. Date incident was first observed.

24-OCT-18

Product Description

7. a) Provide the active ingredient and, if available, the registration number and product name (include all tank mixes). If the product is not registered provide a submission number.

Active(s)

PMRA Registration No.       PMRA Submission No.       EPA Registration No. 2724-797-270

Product Name: Adams Plus Flea And Tick Spray

  • Active Ingredient(s)
    • (S)-METHOPRENE
      • Guarantee/concentration .27 %
    • ETOFENPROX
      • Guarantee/concentration .5 %
    • PIPERONYL BUTOXIDE
      • Guarantee/concentration 1.75 %

7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

Unknown

10. Site pesticide was applied to (select all that apply).

Site: Animal / Usage sur un animal domestique

11. Provide any additional information regarding application (how it was applied, amount applied, the size of the area treated etc).

On October 24, 2018, the owner applied the product to the cat to treat a condition.

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?

Unknown

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Cat / Chat

3. Breed

Domestic Unspecified

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

9.0

7. Weight (provide a range if necessary )

4.0

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>15 min <=2 hrs / >15 min <=2 h

10. Time between exposure and onset of symptoms

<=30 min / <=30 min

11. List all symptoms

System

  • Gastrointestinal System
    • Symptom - Salivating excessively
  • General
    • Symptom - Death

12. How long did the symptoms last?

Persisted until death

13. Was medical treatment provided? Provide details in question 17.

No

14. a) Was the animal hospitalized?

No

14. b) How long was the animal hospitalized?

15. Outcome of the incident

Died

16. How was the animal exposed?

Treatment / Traitement

17. Provide any additional details about the incident

(eg. description of the frequency and severity of the symptoms

About ten minutes after the product was applied on October 24, 2018, the cat developed hypersalivation. Soon after, the cat passed away unattended. The owner then contacted the Animal Product Safety Service (APSS). The APSS veterinarian stated that etofenprox is an ether pyrethroid - the median lethal dose (LD 50) is over 40,000 milligrams per kilogram (mg/kg) and that any serious systemic effects from this insecticide would not be expected with this type of exposure. The APSS veterinarian also stated that in general, significant neurologic signs are not expected with the appropriate use of etofenprox in cats. The APSS veterinarian continued by stating that ingestion may cause a taste reaction (hypersalivation) or vomiting. The APSS veterinarian further stated that this product contains an alcohol and that the most common clinical effects include ataxia, lethargy, and vomiting. Finally, the APSS veterinarian stated that at higher dosages, recumbency, hypothermia, disorientation, vocalization, tremors, tachycardia, hypoglycemia, and acidosis have been encountered and that alcohols will rarely cause coma and seizures. The APSS assistant recommended the owner take the animal to a veterinarian (the owners are potentially interested in a necropsy) and to call back with questions.


To be determined by Registrant

18. Severity classification (if there is more than 1 possible classification

Death

19. Provide supplemental information here

The APSS veterinarian stated that the substance was considered to have a doubtful likelihood of causing the clinical situation. On October 25, 2018, an APSS assistant contacted the clinic to discuss the necropsy. The APSS assistant provided the clinic with additional information for the necropsy process. The regular veterinary staff informed the APSS veterinarian that the clinic had not yet received the body. In the afternoon on October 25, 2018, the regular veterinary staff stated that they had received the cat's remains partially frozen. On November 12, 2018, the gross necropsy with histopathology information was received. The necropsy veterinarian stated that in addition to the multiple hernias and pulmonary incarceration that were noted on gross examination, histological evaluation reveals several additional disease processes affecting this animal, including intestinal lymphoma and cardiac disease. The necropsy veterinarian stated that gross and histological evaluation fails to reveal the cause of the neurologic signs that were documented in the clinical history and that neurotoxin exposure should be considered. Finally, the necropsy veterinarian stated that tissue samples have been obtained and will be saved for 2 weeks for toxicology, which is available upon request for additional fees. On November 13, 2018, an APSS veterinarian contacted the owner to discuss the necropsy results. The APSS veterinarian stated that the cat had multiple issues and that the stress of the application may have pushed her over the edge but that the necropsy did not support that the flea spray itself killed her. The APSS veterinarian confirmed with the owner that the cat was drooling and then 5 minutes later had died and that she did not show any neurologic signs before she died.